Trial Outcomes & Findings for A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery (NCT NCT01650519)

Last Updated: 2016-06-23

Results Overview

Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) upon first possible assessment following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between o and 100.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

51 participants

Primary outcome timeframe

first possible assessment following surgery

Results posted on

2016-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	IV Ibuprofen 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS \< 65 years of age (15 mg NS for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.	IV Ketorolac Either 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds
Overall Study STARTED	20	31
Overall Study COMPLETED	19	31
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	IV Ibuprofen 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS \< 65 years of age (15 mg NS for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.	IV Ketorolac Either 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Ibuprofen n=20 Participants 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS \< 65 years of age (15 mg NS for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.	IV Ketorolac n=31 Participants Either 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds	Total n=51 Participants Total of all reporting groups
Age, Customized Subject greater than or equal to 18 years of age	43 years STANDARD_DEVIATION 12.6 • n=5 Participants	45 years STANDARD_DEVIATION 13 • n=7 Participants	44 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	29 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	30 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	31 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: first possible assessment following surgery

Outcome measures

Outcome measures
Measure	IV Ibuprofen n=19 Participants 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS \< 65 years of age (15 mg NS for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.	IV Ketorolac n=31 Participants Either 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds
Efficacy of IV Ibuprofen for Post-op Pain. VAS at Rest (mm)	8 units on a scale Standard Deviation 6.6	34 units on a scale Standard Deviation 25.0
Efficacy of IV Ibuprofen for Post-op Pain. VAS with Movement (mm)	19 units on a scale Standard Deviation 17.4	41 units on a scale Standard Deviation 25.8

SECONDARY outcome

Timeframe: 24 hours

Measurement of the amount of rescue medication in the postoperative period.

Outcome measures

Outcome measures
Measure	IV Ibuprofen n=19 Participants 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS \< 65 years of age (15 mg NS for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.	IV Ketorolac n=31 Participants Either 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds
Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Rescue Medication in the Postoperative Period Through Discharge Narcotic	5.4 milligrams Standard Deviation 6.02	20.4 milligrams Standard Deviation 15.87
Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Rescue Medication in the Postoperative Period Through Discharge Acetaminophen	162.5 milligrams Standard Deviation 229.81	325 milligrams Standard Deviation 269.90

SECONDARY outcome

Timeframe: 24 hours

Measurement of the time to discharge in the postoperative period.

Outcome measures

Outcome measures
Measure	IV Ibuprofen n=19 Participants 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS \< 65 years of age (15 mg NS for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.	IV Ketorolac n=31 Participants Either 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds
Time to Discharge.	1.8 Hours Standard Deviation 0.12	1.8 Hours Standard Deviation 0.08

SECONDARY outcome

Timeframe: 24 hours

Measurement of patient satisfaction post-procedure. During the post-treatment period, subjects were asked to complete a satisfaction questionnaire (Quality of Recovery - 40 or QoR-40) defining their quality of recovery at 24 hours following surgery. The QoR - 40 is a 40-item questionnaire that provides a global score and subscores across five dimensions of quality of recovery: emotions (minimum score = 6, maximum score = 30), physical comfort (minimum score = 8, maximum score = 40), patient support (minimum score = 7, maximum score = 35), physical independence (minimum score = 5, maximum score = 25), and pain (minimum score = 7, maximum score = 35). Higher subscores represent a better outcome. Subscores are added to create a Global QoR-40 score. Global scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).

Outcome measures

Outcome measures
Measure	IV Ibuprofen n=13 Participants 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS \< 65 years of age (15 mg NS for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.	IV Ketorolac n=18 Participants Either 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds
Patient Satisfaction. Emotions	20.2 units on a scale Standard Deviation 2.35	20.7 units on a scale Standard Deviation 2.25
Patient Satisfaction. Physical Comfort	28.3 units on a scale Standard Deviation 4.39	26.9 units on a scale Standard Deviation 2.98
Patient Satisfaction. Patient Support	30.5 units on a scale Standard Deviation 1.20	29.0 units on a scale Standard Deviation 3.93
Patient Satisfaction. Physical Independence	22.2 units on a scale Standard Deviation 2.55	21.3 units on a scale Standard Deviation 3.32
Patient Satisfaction. Pain	9.5 units on a scale Standard Deviation 3.45	10.9 units on a scale Standard Deviation 3.34

SECONDARY outcome

Timeframe: 24 hours

Measurement of the incidence of serious adverse events.

Outcome measures

Outcome measures
Measure	IV Ibuprofen n=20 Participants 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS \< 65 years of age (15 mg NS for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.	IV Ketorolac n=31 Participants Either 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds
Incidence of Serious Adverse Events (SAEs).	0 Number of Events	0 Number of Events

SECONDARY outcome

Timeframe: 24 Hours

Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) in the post-surgical period through 24 hours post-procedure. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject's mark. The score would be between 0 and 100. Subject's were contacted at 24 hour post-discharge during a follow-up phone contact and asked to completed the VAS at Rest and VAS with Movement and return both completed VAS assessments via the envelope provided. The analysis was performed on the VAS assessments returned to the study site.

Outcome measures

Outcome measures
Measure	IV Ibuprofen n=10 Participants 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS \< 65 years of age (15 mg NS for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.	IV Ketorolac n=13 Participants Either 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds
Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Pain Intensity as Assess by Patient Pain Intensity (VAS) in the Post-surgical Period, Through 24 Hours VAS at Rest (mm)	4 units on a scale Standard Error 3.7	13 units on a scale Standard Error 10.8
Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Pain Intensity as Assess by Patient Pain Intensity (VAS) in the Post-surgical Period, Through 24 Hours VAS with Movement (mm)	12 units on a scale Standard Error 12.2	23 units on a scale Standard Error 16.5

SECONDARY outcome

Timeframe: 24 hours

Measurement of the amount of time to rescue medication in the postoperative period.

Outcome measures

Outcome measures
Measure	IV Ibuprofen n=20 Participants 800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS \< 65 years of age (15 mg NS for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes.	IV Ketorolac n=31 Participants Either 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4. IV ketorolac: 30 mg ketorolac for patients \< 65 years of age (15 mg ketorolac for patients \> 65 years of age) administered intravenously over no less than 15 seconds
Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Time to Rescue Medication in the Postoperative Period Through Discharge	1.7 Hours Standard Deviation 0.19	1 Hours Standard Deviation 0.11

Adverse Events

IV Ibuprofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IV Ketorolac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy Rock, PhD

Cumberland Pharmaceutical Inc.

Phone: 615-255-0068

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place